Otto Bock 4R103 Instructions For Use Manual page 7

adjustments can be made either in the frontal plane (medial or lateral)
or in the sagittal plane (anterior or posterior). This is also possible
while wearing the prosthesis.
1.2 Combination possibilities
This prosthetic component is part of the Ottobock modular system
and can be combined with other products of this modular system.
2 Intended use
2.1 Indications for use
The product is to be used solely for lower limb prosthetic fittings.
2.2 Area of application
Approved for a body weight of up to 85 kg.
Ottobock recommends the use of structural components with a dia­
meter of 34 mm when elevated loads are expected (e.g. for a transtibi­
al prosthesis).
2.3 Environmental conditions
Allowable environmental conditions
Temperature range for use: -10 °C to +60°C
Allowable relative humidity 0 % to 90 %, non-condensing
Unallowable environmental conditions
Mechanical vibrations or impacts
Perspiration, urine, fresh water, salt water, acids
Dust, sand, highly hygroscopic particles (e.g. talcum)
2.4 Service Life
In general, all modular adapters are tested by the manufacturer for
3 million load cycles. Depending on the patient's level of activity, this
corresponds to a service life of 3 to 5 years.
3 Safety
3.1 Explanation of warning symbols
Warning regarding possible risks of accident or
CAUTION
injury.
Warning regarding possible technical damage.
NOTICE
3.2 General safety instructions
CAUTION
Excessive strain on the product
Risk of injury due to breakage of load-bearing components
► Use the product according to the specified area of application
(see Page 7).
CAUTION
Unallowable combination of prosthetic components
Risk of injury due to breakage or deformation of the product
► Only combine the product with prosthetic components that are
approved for that purpose.
► Based on the instructions for use of the prosthetic components,
verify that they may be combined with each other.
CAUTION
Use under unallowable environmental conditions
Risk of injury due to damage to the product
► Do not expose the product to unallowable environmental condi­
tions.
► If the product has been exposed to unallowable environmental
conditions, check it for damage.
► If damage is apparent or in case of doubt, do not continue using
the product.
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